Legacy Review Specialist

For a major client, we are looking for contract resources (locations: BL, SO, TI) as

LEGACY REVIEW SPECIALISTS

Job description/Functional experience requirements:

- With oversight from the Core Team Leads, determine and report on the state of compliance of the quality system versus regulatory standards (ISO, FDA, etc.).
- Audit sites' procedures to the standards and report out on findings (both current state and retrospectively.
- Make recommendations to achieve compliance where shortfalls are found.
- Provide Audit reports as directed.
- Perform CAPA root cause and corrective/preventive action as necessary.
- Perform CAPA verification of effectiveness as necessary.
- Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines.
- Analysing reports NCR, CAPA files.
- Analysing inspection activities.
- Analysing maintenance reports and monitoring data.
- Bringing in of improvement proposals, which increase the productivity and efficiency of manufacturing and facility and operational practices.
- Consultancy and guidance of all employees regarding maintenance, NCR, CAPA etc.

Knowledge thus, the validation requirement.
- The resource must be proficient in the related ISO 13485 standards sections and related 21 CFR 820 regulatory subchapters
- The resource should have the ability to travel, to perform internal audits and be able to work independently - with minimal supervision
- Degree as an Engineer (Mechanical)
- Be able to work with various databases to extract and report out required information (Excel, Access, Q-DAS, SAP etc.).
- Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines.
- Fluently German/English spoken and written

Experience:

- Minimum of 5 years quality/compliance experience in the medical device or pharmaceutical industries.
- Prior experience in medical device/pharmaceutical remediation preferred.
- Familiarity and interaction experience with regulatory auditing bodies preferred.
- Documented training in FDA QSR, ISO 13485/9001 required.
- Proficient in the use of spread sheet software (Access/Excel etc.).
- Solid knowhow of FDA QSR, ISO 13485

Are you interested in this position? We are looking forward to receive your application. Many thanks.